Condition category
Musculoskeletal Diseases
Date applied
20/01/2017
Date assigned
07/02/2017
Last edited
10/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Clubfoot is a deformity of the foot and ankle that some babies are born with. If treated early, the position and function of the foot can generally be corrected quite easily. Many children however do not receive this treatment which can lead to pain and difficulty walking as they grow up (neglected clubfoot). This is a particular problem in poor countries where people are unable to easily access medical care. It is a problem for individuals and families involved as in many cultural settings it excludes individuals and families from social integration causing indignity. Between the ages of two and ten, most children with clubfoot can be treated using a technique called serial casting (applying and removing a series of lightweight casts on the affected area), however this does not generally work in children over 12. This study is looking at two treatments that can be used for difficult-to-treat feet. The first involves surgery to remove bones and joints within the foot to straighten it and stiffen it and the second involves putting wire pins through the bones and connecting them up to a device (Ilizarov fixator) that gradually pulls on the bones to line them up. The aim of this study is to compare the effectiveness of these treatments.

Who can participate?
Children aged 2-16 who have a neglected clubfoot that could not be treated with serial casting.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive treatment with surgery to release the tight tendons in the foot and then, in a second procedure, removing bones and joints within the foot to straighten it and stiffen it, followed by use of a cast for 3-5 months. Those in the second group undergo treatment using an Ilizarov fixator. This involves putting wire pins through the bones and connecting them up to a devise that gradually pulls on the bones to line them up. After the foot is straight it is put into a plaster cast. At the start of the study and after one year, participants in both groups complete a range of assessments to measure their pain levels and foot function.

What are the possible benefits and risks of participating?
Participants who take part benefit from receiving treatment that they would not have otherwise had access to. There are no notable risks of participating other than the general risks associated with having foot surgery.

Where is the study run from?
CURE Ethiopia Children's Hospital (Ethiopia)

When is the study starting and how long is it expected to run for?
May 2015 to January 2019

Who is funding the study?
CURE International UK (UK)

Who is the main contact?
Mr Tim Nunn
tim.nunn@cure.org

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tim Nunn

ORCID ID

Contact details

SIM PO Box 127
Press Compound
Addis Ababa
-
Ethiopia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

mosi.nrerc/0084/2015

Study information

Scientific title

A trial comparing traditional surgical approach with Ilizarov soft tissue distraction in the treatment of clubfoot that has never had prior treatment and will not respond to casting

Acronym

NRCT

Study hypothesis

Null hypothesis:
There is no difference between functional outcomes of joint sparing compared with joint invasive approaches at 1 year when treating neglected resistant clubfeet in young children.

Ethics approval

Ethiopian Ministry of Science and Technology National Research Ethics Review Committee (NRERC), 17/12/2015, ref: mosi.nrerc/0084/2015

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neglected clubfoot

Intervention

Participants are randomised to one of two groups using sealed envelope randomisation in a 1:1 ratio.

Group 1: Participants undergo surgery with Percutaneous soft tissue releases of the tendo Achilles in a 3 step manner (Hoke) then the application of the Ilizarov apparatus foot frame. This involves 2 tibial rings and 2 foot 1/2 rings fixed with tensioned wires. The frame is adjusted daily by 1mm and after correction the frame is removed, a long leg cast is applied and 6 weeks later a Tibialis anterior tendon transfer performed.

Group 2: Participants undergo a staged triple arthrodesis. This involves initial soft tissue releases of the posterior tendinous structures and posterior ankle joint capsulotomy, plantar fascia release and abductor hallucis release at the distal tendinous portion. 6 weeks later a triple arthrodesis is performed. This involves bone resection and fusions of the talo-calcaneal, talo-navicular and calcaneao-cuboid joints.

Follow up involves clinic review, pedobarography and questionnaires. And takes place after 1 year.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Current primary outcome measure as of 10/04/2018:
Laaveg-Ponseti score (a questionnaire that includes patient assessments of satisfaction, function and pain assessments and physician assessments of foot position motion and gait) at 1 year after treatment

Original primary outcome measure:
Foot function is measured using the Oxford foot and Ankle score at baseline and 1 year

Secondary outcome measures

Current secondary outcome measures as of 10/04/2018:
1. Footprint area and peak pressures are measured using a pedobarograph at baseline and 1 year
2. Function is assessed using the Roye score and Bangla score at baseline and 1 year
3. Foot function is measured using the Oxford Foot and Ankle Questionnaire (OxFAQ) score at baseline and 1 year

Original secondary outcome measures:
1. Footprint area and peak pressures are measured using a pedobarograph at baseline and 1 year
2. Function is assessed using the Roye score and Bangla score at baseline and 1 year

Overall trial start date

01/05/2015

Overall trial end date

01/01/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 2-16
2. Neglected clubfoot
3. Idiopathic
4. Not responding to casting

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Neuromuscular clubfoot
2. Syndromic clubfeet

Recruitment start date

01/11/2016

Recruitment end date

01/09/2017

Locations

Countries of recruitment

Ethiopia

Trial participating centre

CURE Ethiopia Children's Hospital
Next to Hamle 19 Park
Addis Ababa
-
Ethiopia

Sponsor information

Organisation

CURE International UK

Sponsor details

35-43 Lincoln's Inn Fields
London
WC2A 3PE
United Kingdom

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

CURE International UK

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in an International Orthopaedic high-impact journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/04/2018: The primary outcome measure and secondary outcome measures have been changed.